The present invention is an apparatus and method for treating obesity in humans, and particularly, a device for endoscopic insertion into the stomach of a human to cause a reduced desire for eating.
Obesity is arguably one of the most serious health problems in the United States, afflicting over 60 million people of all ages. Apart from physical and psychological effects, especially on the younger population, obesity predisposes to serious diseases such as coronary artery disease, hyperlipidemia, hypertension, and diabetes mellitus. The costs to the health system is a staggering $39 billion per year.
Weight reduction can be achieved either by increasing caloric expenditure through exercise and/or by reducing caloric intake. Reduced caloric intake can be achieved in a number of ways; surgical procedures to reduce the stomach capacity or increase the food transit time in the gastrointestinal tract, appetite suppressants like amphetamines or noradrenargic compounds, or other methods such as introducing balloons into the stomach. Surgical procedures to reduce the stomach capacity or increase food transit time in the gastrointestinal tract carry with them the risk of surgery as well as post-operative complications. The appetite suppressants act on the central nervous system and are associated with considerable morbidity and side effects. Balloon inserts have several disadvantages, which include failure due to bursting or dislodging, intestinal obstruction (blockage of the intestinal lumen), and the requirement of complicated devices and/or procedures to secure the balloons within the stomach.
Accordingly, there is a need for a non-surgical stomach insert that is easily inserted and/or removed from the stomach, that does not have the tendency to dislodge into the distal intestinal tract and cause obstruction, and that does not significantly obstruct the gastric lumen.
The present invention is an endoscopic stomach insert for treating obesity in humans by reducing the desire for eating, comprising a base-sized for passing through a human mouth and esophagus; a plurality of flexible spokes coupled at one end thereof to the base and circumferentially arranged about the base central axis, where the spokes are biased to extend substantially radially outward from the base; and a retainer for releasably coupling the distal portions of the spokes within close proximity to each other about the central axis of the base. The apparatus is thus adapted to be passed through the mouth and esophagus and into a human stomach, and upon releasing the retainer within the stomach, the spokes are biased to flare outwardly and apply pressure to the stomach, thus causing a sensation of fullness within the stomach and reducing the desire for eating.
In a preferred embodiment, the endoscopic stomach insert comprises a disc having a diameter sized for passing through a human mouth and esophagus, where the disc includes a guide-hole extending axially therethrough for receiving a guide-wire; at least three flexible plastic blades, each of the blades being substantially flat and curved with respect to the longitudinal axis and having a substantially blunt distal end, and each of the blades being coupled at its proximate end to the disc, such that its concave surface faces downwardly or inwardly with respect to the central axis of the disc; a retainer for coupling the blades within close proximity to each other about the lower end of the disc and about the central axis of the disc; and a projection extending from the upper surface of the disc.
Each blade also includes an eyelet extending from its concave surface at a point approximately one-quarter of the way from its proximate end. And the retainer is preferably a severable elastic band extending through each of the eyelets.
The blades are circumferentially arranged about the center axis of the disc and are biased to extend substantially radially outwardly and downwardly from the disc, such that when the blades are not retained together by the elastic band, they tend to fan out to form a cup-shaped or dome-shaped cage or skeleton.
The disc is adapted to ride on a guide-wire extending into a human mouth and esophagus and into the stomach, such that the insert can be deposited within the stomach. Upon severing the elastic band within the stomach, the blades will be biased to flare outwardly such that the convex surfaces of the blades will apply pressure to the stomach, thus causing a sensation of fullness within the stomach and reducing the desire for eating.
The projection extending from the upper surface of the disc provides means for gripping the insert with an endoscopic instrument (i.e. forceps) such that the insert can be extracted back out from the stomach, through the esophagus, and out through the mouth.
The endoscopic procedure for treating obesity using the above insert comprises the steps of: endoscopically extending a guide-wire into a patient's mouth, through the patient's esophagus, and into the patient's stomach; guiding the endoscopic stomach insert along the guide-wire, into the patient's mouth, through the patient's esophagus, and into the patient's stomach; endoscopically releasing the retainer such that the spokes or blades will flare outwardly and apply pressure to the stomach, thus causing the patient to experience a sensation of fullness within the stomach and reducing the patient's desire for eating.
Accordingly, it is an object of the present invention to provide an endoscopic stomach insert and method for the non-surgical treatment of obesity; it is a further object of the present invention to provide an endoscopic stomach insert that does not substantially obstruct the passage of food through the gastric lumen; it is a further object of the present invention to provide an endoscopic stomach insert that does not have the tendency to dislodge from the stomach and thus subsequently lodge into the distal intestinal tract, causing an obstruction; and it is also an object of the present invention to provide an endoscopic insert that is easily removed from the stomach once the patient's desired weight-loss has been achieved.
These and other objects and advantages of the present invention will be apparent from the following description, the accompanying drawings, and the appended claims.